HerniaMASHNCT04197271
Management of Acutely Symptomatic Hernia
An observational study of Hernia and Emergencies, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Acutely symptomatic abdominal wall hernia can cause many symptoms and complications. They can be associated with levels of morbidity beyond that seen in emergency laparotomy. There is limited data to guide practice in this field. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Emergencies, Surgery--Complications
- What is being tested?
- Emergency Hernia Repair and Conservative management
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential participants will be identified from attendance at UK hospitals which provide emergency surgical services.
Who may be able to join
- Patients aged 18 years and over
- Patients admitted directly to the emergency surgery service (via A+E or GP)
- Patients referred to the emergency surgical team by another inpatient specialty
- Patients with a diagnosis of an acutely symptomatic hernia made by a specialist surgical trainee (ST3+) or Consultant Surgeon
- Willing to take part in the study
Who cannot join
- Patients under 18 years of age
- Pregnant women
- Patients with a symptomatic parastomal, hiatal or diaphragmatic hernia
- Patients with a traumatic hernia
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU
About this study
Official title: Management of Acutely Symptomatic Hernia: An Observational Study
Acutely symptomatic abdominal wall hernia can cause many symptoms and complications. They can be associated with levels of morbidity beyond that seen in emergency laparotomy. There is limited data to guide practice in this field. This observational cohort study will explore variation in practice around assessment, repair and outcomes of hernias treated in the emergency setting.
Read the detailed description
There are many different types of hernia, with the most common being in the groin or at the umbilicus. Hernias affect a significant proportion of the population and can vary from producing no symptoms at all, to causing a blockage to the bowel that requires urgent surgery. Hernias affect people of all ages and degrees of health, but become increasingly common with age. As our population ages and therefore becomes generally more unwell, the risks of surgery increase. Recent evidence suggests that emergency hernia repair is associated with worse outcomes than planned procedures. At present there are limited guidelines for the management of acutely symptomatic hernias and therefore practice varies between hospitals.
This cohort study will capture information on patients treated in the UK for acutely symptomatic hernia, and will provide information on variation in assessment, and technical aspects of repair. It will also capture health utility data out to 90 days post discharge from hospital.
- Conditions
- Hernia, Emergencies, Surgery--Complications
- Being tested
- Emergency Hernia Repair, Conservative management
- Keywords
- outcome, hernia, emergency
- Medical subject headings
- Hernia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Hernia RepairProcedure or surgery
Emergency repair of hernia using method selected by treating surgeon.
Conservative managementOther
Also called Non-operative management
Treatment of hernia without resort to surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with acutely symptomatic abdominal wall hernia | Patients presenting to emergency surgical services with acutely symptomatic abdominal wall hernia (excluding parastomal). Receives: Procedure: Emergency Hernia Repair; Other: Conservative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital morbidity
As defined using the comprehensive complication index
Measured: up to 28 days after surgery
Secondary outcomes (4)
Mortality
Death occuring (binary)
Measured: Measured at baseline, 30 days post discharge, and 90 days post recruitment
Hospital length of stay
Time from admission to discharge measured in days
Measured: Within 30 days of recruitment to study
Unplanned readmission within 30 days
Unplanned readmission to hospital for any reason following treatment of hernia
Measured: Up to 30 days of recruitment
Change in health utility
Measured using EQ-5D-5L questionnaire
Measured: Measured at baseline, 30 days post discharge and 90-days post recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start3 Mar 2020
- Primary completion30 Nov 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew J Lee, MRCS PhD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197271
- Sponsor's protocol ID
- STH20908
- Acronym
- MASH
- Status last verified
- May 2026
- First submitted
- 9 Sep 2019
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Proctor VK, O'Connor OM, Burns FA, Green S, Sayers AE, Hawkins DJ, Smart NJ, Lee MJ; MASH Collaborators. Surgical site infections after emergency hernia repair: substudy from the Management of Acutely Symptomatic Hernia (MASH) study. BJS Open. 2023 Jan 6;7(1):zrac155. doi: 10.1093/bjsopen/zrac155.
PubMed 36633418
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Acutely Symptomatic Hernia: An Observational Study
- ClinicalTrials.gov ID
- NCT04197271
- Acronym / sponsor ID
- MASH / STH20908
- Conditions
- Hernia, Emergencies, Surgery--Complications
- Keywords
- outcome, hernia, emergency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acutely symptomatic abdominal wall hernia can cause many symptoms and complications. They can be associated with levels of morbidity beyond that seen in emergency laparotomy. There is limited data to guide practice in this field. This observational cohort study will explore variation in practice around assessment, repair and outcomes of hernias treated in the emergency setting.
Detailed description
There are many different types of hernia, with the most common being in the groin or at the umbilicus. Hernias affect a significant proportion of the population and can vary from producing no symptoms at all, to causing a blockage to the bowel that requires urgent surgery. Hernias affect people of all ages and degrees of health, but become increasingly common with age. As our population ages and therefore becomes generally more unwell, the risks of surgery increase. Recent evidence suggests that emergency hernia repair is associated with worse outcomes than planned procedures. At present there are limited guidelines for the management of acutely symptomatic hernias and therefore practice varies between hospitals.
This cohort study will capture information on patients treated in the UK for acutely symptomatic hernia, and will provide information on variation in assessment, and technical aspects of repair. It will also capture health utility data out to 90 days post discharge from hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acutely symptomatic abdominal wall hernia | – | Procedure: Emergency Hernia Repair, Other: Conservative managementPatients presenting to emergency surgical services with acutely symptomatic abdominal wall hernia (excluding parastomal). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants will be identified from attendance at UK hospitals which provide emergency surgical services.
Key inclusion criteria (5 listed)
- Patients aged 18 years and over
- Patients admitted directly to the emergency surgery service (via A+E or GP)
- Patients referred to the emergency surgical team by another inpatient specialty
- Patients with a diagnosis of an acutely symptomatic hernia made by a specialist surgical trainee (ST3+) or Consultant Surgeon
- Willing to take part in the study
Key exclusion criteria (5 listed)
- Patients under 18 years of age
- Pregnant women
- Patients with a symptomatic parastomal, hiatal or diaphragmatic hernia
- Patients with a traumatic hernia
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency Hernia RepairEmergency repair of hernia using method selected by treating surgeon. | Procedure or surgery | Patients with acutely symptomatic abdominal wall hernia |
| Conservative managementAlso: Non-operative managementTreatment of hernia without resort to surgery | Other | Patients with acutely symptomatic abdominal wall hernia |
Primary outcome
In hospital morbidity
Time frame: up to 28 days after surgery
As defined using the comprehensive complication index
4 secondary outcomes
Mortality
Time frame: Measured at baseline, 30 days post discharge, and 90 days post recruitment
Hospital length of stay
Time frame: Within 30 days of recruitment to study
Unplanned readmission within 30 days
Time frame: Up to 30 days of recruitment
Change in health utility
Time frame: Measured at baseline, 30 days post discharge and 90-days post recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 36633418Proctor VK, O'Connor OM, Burns FA, Green S, Sayers AE, Hawkins DJ, Smart NJ, Lee MJ; MASH Collaborators. Surgical site infections after emergency hernia repair: substudy from the Management of Acutely Symptomatic Hernia (MASH) study. BJS Open. 2023 Jan 6;7(1):zrac155. doi: 10.1093/bjsopen/zrac155.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J Lee, MRCS PhD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia and Emergencies, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In hospital morbidity (time frame: up to 28 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.